The Nuts and Bolts of Implementing HIV Pre-Exposure Prophylaxis (PrEP) in Clinical Settings

Is there anything that patients and providers should know about cost-related issues? What kind of coverage is there for PrEP?

I think that's a moving target, as well. Once the FDA approves a drug for an indication, then typically what happens is that Medicaid will start to reimburse. Then it will be the commercial insurances, and then the pharmaceutical companies -- they have [traditionally] provided patient assistance programs for patients that can't afford the medications.

But I think that is the big elephant in the room: If PrEP is not covered, that's really going to limit its use, particularly for patients who just can't afford it. Then we're going to have this further split of only the wealthy being able to afford an effective prevention tool.

But again, typically, after the FDA approves a drug for indication, then the commercial insurances, Medicaid, etc., will start to reimburse the product.

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All right, it still sounds like a bit of a question mark on that front. It sounds like there are a number of question marks on many fronts, as we move forward toward the actual implementation of PrEP in clinical settings. What other questions are there, at least in your mind, as far as the rollout goes?

I think people are waiting. They're in this kind of limbo with PrEP. There's an indication; it's been approved; the science is there; the data is there; the studies are there. But there is still a lot of confusion about: "How am I, as a doctor, going to be able to do this?" And more importantly: "Who can I turn to if I can't do this? What are my support tools?"

I think a couple of the key obstacles are just going to be buy-in: buy-in from the medical profession and the medical societies. Once we start to get that, then I think that buy-in will trickle down, and I think there will be more acceptance about this being as effective as, like, malaria prophylaxis or screening your patients who are diabetics with eye exams.

Again, I think the whole reimbursement issue is a big obstacle -- not just for the medications, but for the actual medical visits. How am I going to get reimbursed for these multiple visits that I'm going to have to do for patients who are on PrEP?

Also, there's a bit of uncomfortableness about having to discuss these issues that often go with high-risk HIV acquisition -- substance use, intravenous drug use, etc. -- all of these behaviors. "How can I, as a sole provider, manage these issues?"

I think all of these issues right now are causing a little bit of unrest, a little bit of uncomfortableness. That's why I don't really think we're seeing people grabbing the reins on this and moving forward.

I also think you have to really be thoughtful about the infrastructure of how you're going to set up dispensing PrEP, and what's going to be the context of that visit. Some ideas that have come out are that you may want to incorporate this as a sexual health clinic, or a men's health clinic, or a transgender sex health clinic [would]: where patients can come in; they can get treated for their sexually transmitted infections; get HIV testing. Then one could determine their risk for HIV acquisition and, with a team-based approach, start to move forward with PrEP.

I think that's how I would feel most comfortable: if I, as a provider, also had a team that I could work with. What I'm thinking about is a social worker who could work with me, or with a provider, in terms of reinforcing the messaging of risk reduction, distributing condoms, making sure they're coming in, getting tested and adhering to their medications.

Because of those unknowns about how best PrEP would be dispensed, I think you're right: I don't think that there's been a big scale-up quite just yet.

It's probably also worth noting, to one of your last points there, that even in the context of a clinical setting -- where there might be only a single provider in an office and one assistant -- throughout the country there are still HIV service organizations that are staffed by people who might be pretty knowledgeable about this, and might be willing to lend a hand.

Yeah, absolutely. I think that those are going to be the best models for PrEP, because just like you said, I think they are best equipped right now.

Organizations that offer HIV services: I think this is a great way to expand their service portfolio to reach out to those that are HIV negative, but at high risk. So I think that's a great suggestion, and I think that's what we'll start seeing: HIV service organizations, designated AIDS centers, really maybe taking the lead on PrEP.

Do you agree with the argument that some have made during the lead-up to PrEP's approval that, if people start taking PrEP widely, they will stop taking other risk-reduction measures, and might ultimately end up increasing their risk? Not just necessarily for HIV, but for other sexually transmitted diseases, also?

That's a very legitimate concern. The data to date has not supported that. The iPrEx trial did show an increase in condom use and a decrease in sexually transmitted infections.

To be fair, as you noted earlier, a lot of those pre-approval studies for PrEP involved more comprehensive prevention that was also done alongside the provision of PrEP. They were giving out condoms. They were counseling people on safer sex.

Right, and I think that that is a legitimate concern. That's why I really do think that you have to be very mindful about, when you decide to initiate PrEP, that you think about these types of contingencies. I think that an agreement between patient and provider, or between the patient and the health care team, about how PrEP is best used, how it can be most effective, really needs to be discussed. I think that there should be "stopping rules" for when PrEP could be irresponsible or may lead to more harm.

But that's the real-world data that I don't think we have quite just yet. Once PrEP does become available, are there going to be certain groups that now feel it gives them license to forgo the condom, to forgo having safer sex?

In Switzerland, they just published data that, when they looked at the rates of new hepatitis C infections in a cohort of patients -- and this is very recently -- there were more new hepatitis C infections in MSM, or males who have sex with males, than in the intravenous drug using population. I think [those data] support a lot of [these] issues. The support of needle exchange [for instance] -- but also that there are other pathogens, other diseases, that are transmitted through unsafe sex. I think one of the more concerning ones is hepatitis C, but also other sexually transmitted infections as well. So I think that is a potential risk. But that argument, in and of itself, I don't think should put the kibosh on PrEP.

Again, there has to be thought in how a provider, an institution, an organization, is going to dispense PrEP. I think there have to be very clear discussions that are ongoing about how PrEP is not something to be used by itself; that it has to be part of a prevention package.

Is there anything that we haven't touched on that you'd like to note about PrEP before we close up?

I think we did cover a lot of ground. I think PrEP, just like PEP [post-exposure prophylaxis] and antiretroviral medications in those that are HIV positive, is going to mature and advance. I think that the therapies are going to change over time, and that -- as it starts to get implemented, as it starts to get scaled up -- we're going to learn some very important lessons.

Chemoprophylaxis is something that could potentially really change the HIV epidemic, not just in the U.S., but around the world. Because we really do have to do something. There are still 50,000-plus new infections every year [in the U.S.]. We've done really lousy with HIV prevention, I think because it's difficult to change behavior. So here's something that we can combine with behavioral interventions. It's something that we can use as a catalyst to engage patients in healthy lifestyles.

Dr. Urbina, thank you so much for taking the time to talk about this.

This transcript has been edited for clarity.

Myles Helfand is the editorial director of TheBody.com and TheBodyPRO.com.

Comment by: Joseph H.
(Minneapolis)
Tue., Oct. 2, 2012 at 6:43 pm EDT
One concern that I have not heard discussed is whether successful transmission in someone who is using Truvada prophylaxis could result in dominance of a Truvada-resistant virus strain. We could presume that prophylaxis adherence will prevent transmission 100% of the time. It seems more likely that as the numbers of people using prophylaxis increases, there will be cases of successful transmission in this population.

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